Agricultural Biotechnology: Background and Recent Issues

Tadlock Cowan
Analyst in Natural Resources and Rural Development

Geoffrey S. Becker
Specialist in Agricultural Policy

U.S. soybean, cotton, and corn farmers have rapidly adopted genetically engineered (GE) varieties of these crops since their commercialization in the mid-1990s. Over the last decade, GE varieties in the United States have increased from 3.6 million acres to 143 million acres. Worldwide, 25 countries planted GE crops on approximately 309 million acres in 2008. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries. As adoption has spread, policy debates have continued over the costs and benefits of GE products. 

Ongoing concerns include the impacts of GE crops on the environment and food safety, and whether GE foods should be specially labeled. Underlying these issues is the question of whether U.S. regulation and oversight of biotechnology—with responsibilities spread primarily among the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA)—are adequate, particularly as newer applications, for example, biopharmaceuticals (drugs manufactured with the use of GE crops or animals) or stacked GE traits in single organisms, emerge that did not exist when the current regulatory regime was established. 

Regulatory noncompliance incidents most pointedly raise concerns about the adequacy of existing U.S. regulatory structures. About 16 major events have occurred since 1995, according to USDA's Animal and Plant Health Inspection Service (APHIS). Another recurring concern has been the adequacy of APHIS's environmental assessments for deregulating GE plants. In 2006, a U.S. District Court held that USDA's environmental analysis for a variety of GE alfalfa was inadequate and ordered further planting to cease until an environmental impact analysis was completed. A similar case involves GE sugar beets. In 2005, trace amounts of an unapproved GE rice were found in samples of the 2005 crop of U.S. long grain rice. 

In October 2008, APHIS announced the first revision of its biotechnology regulations since their promulgation in 1987. Proposed changes include a multi-tiered permitting system, new risk categorizations for assessing environmental releases of GE organisms, regulation of GE plants that produce pharmaceutical and industrial compounds, and new standards for low-level presence of regulated GE products. A final rule on the proposed changes has not yet been published. Other recent issuances include FDA's January 2009 final guidance on regulation of GE animals and products. APHIS is now seeking public comment and data concerning ongoing and future research on GE animals. In a ruling in January 2008, APHIS published its final guidance on the safety of meat and milk from cloned animals. 

Some U.S. agricultural export markets, notably the European Union (EU), have taken a more restrictive approach to regulating agricultural biotechnology than the United States, presenting obstacles for U.S. farm exports. In 2006, a World Trade Organization (WTO) dispute panel ruled against the EU's de facto moratorium on approvals of new GE crops from 1998 to 2004. The parties (Canada and the United States) subsequently agreed to extend the time for EU compliance with the ruling to January 11, 2008. Positive action from the EU remains slow. U.S. agricultural interests remain concerned that stricter EU rules for labeling and tracing GE products will continue to discriminate against U.S. exports. Congress generally has been supportive of GE agricultural products, although some Members have expressed wariness about their adoption and regulation. Legislative activity in the 110th Congress was modest. There has been no legislative activity to date in the 111th Congress on agricultural genetic engineering. .


Date of Report: January 28, 2010
Number of Pages: 38
Order Number: RL32809
Price: $29.95

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